Comparison of Cardiac Index and Cardiac Output Effect During Maintenance Hemodialysis Between Acetate-Free and Acetate-Based Online Hemodiafiltration

Sponsor

Chulalongkorn University (Other)

Overall Status

Completed

CT.gov ID

NCT01778283

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

21.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to detemine whether effect of Acetate-free solution on cardiac index and cardiac output measured by saline dilution techniques compares with Acetate-based solution in online-hemodiafiltration

Condition or Disease	Intervention/Treatment	Phase
End-stage Renal Disease	Biological: Acetate-free dialysis solution	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Comparison of Cardiac Index and Cardiac Output Effect During Maintenance Hemodialysis Between Acetate-Free and Acetate-Based Online Hemodiafiltration

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acetate-free solution first Acetate-free solution first : hemodialysis 4 hours with Acetate-free solution (Acetate 0 mEq/L Citrate 2 mEq/L) at the first session after enrollment, and then switch to Acetate-based solution (Acetate 3 mEq/L Citrate 0 mEq/L) at the next 4-hr hemodialysis session	Biological: Acetate-free dialysis solution the hemodialysis solution that does not contain acetate as buffer
Active Comparator: Acetate-based solution first Acetate-based solution first : hemodialysis 4 hours with Acetate-based solution (Acetate 3 mEq/L Citrate 0 mEq/L) at the first session after enrollment, and then switch to Acetate-free solution (Acetate 2 mEq/L Citrate 2 mEq/L) at the next 4-hr hemodialysis session	Biological: Acetate-free dialysis solution the hemodialysis solution that does not contain acetate as buffer

Arm

Intervention/Treatment

Experimental: Acetate-free solution first

Acetate-free solution first : hemodialysis 4 hours with Acetate-free solution (Acetate 0 mEq/L Citrate 2 mEq/L) at the first session after enrollment, and then switch to Acetate-based solution (Acetate 3 mEq/L Citrate 0 mEq/L) at the next 4-hr hemodialysis session

Biological: Acetate-free dialysis solution

the hemodialysis solution that does not contain acetate as buffer

Active Comparator: Acetate-based solution first

Acetate-based solution first : hemodialysis 4 hours with Acetate-based solution (Acetate 3 mEq/L Citrate 0 mEq/L) at the first session after enrollment, and then switch to Acetate-free solution (Acetate 2 mEq/L Citrate 2 mEq/L) at the next 4-hr hemodialysis session

Biological: Acetate-free dialysis solution

the hemodialysis solution that does not contain acetate as buffer

Outcome Measures

Primary Outcome Measures

cardiac index [6 months]
cardiac index and cardiac output was measured by ultrasound dilution technique
Cardiac output [6 months]
cardiac index and cardiac output was measured by ultrasound dilution technique

Secondary Outcome Measures

blood pressure [6 months]
peripheral vascular resistance [6 moths]
Patients' symptoms [6 months]
dizziness, palpitation, nausea, cramp, numbness

Other Outcome Measures

cardiac marker, serum electrolyte, inflammatory marker [January 2013]
BUN, creatinine, serum sodium, serum potassium, serum bicarbonate, serum calcium, ionized calcium, serum magnesium, serum osmol, troponin T, NT-proBNP, CKMB, hs-CRP

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

End-stage renal disease patients with age over 20 years and stable clinical status
Dialytic age > 6 months
Maintenance hemodialysis with online-hemodiafiltration mode at King Chulalongkorn Memorial Hospital
Use arteriovenous fistula or arteriovenous graft as vascular access for hemodialysis
No vascular access recirculation
No liver impairment
No severe, intractable metabolic acidosis or alkalosis (HCO3 <15, >30)
No pre-existing severe, intractable hypocalcemia (Ca < 7.5) or clinical of hypocalcemia

Exclusion Criteria:

On hemodialysis via tunnel catheter
Vascular access recirculation
Liver dysfunction
Severe, intractable metabolic acidosis or alkalosis (HCO3 <15, >30)
Pre-existing severe, intractable hypocalcemia (Ca < 7.5) or clinical of hypocalcemia
Acute or recent myocardial ischemia or congestive heart failure (within 1 months)
Threatening arrhythmia (VT, VF, sustained SVT, AF with rapid ventricular response)
Patients affected by acute or chronic infections, malignant tumor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Chulalongkorn University	Bangkok		Thailand	10330

Sponsors and Collaborators

Chulalongkorn University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Khajohn Tiranathanagul, Doctor, Chulalongkorn University

ClinicalTrials.gov Identifier:

NCT01778283

Other Study ID Numbers:

297/55

First Posted:

Jan 29, 2013

Last Update Posted:

Feb 15, 2013

Last Verified:

Feb 1, 2013

Additional relevant MeSH terms:

Kidney Failure, Chronic

Dialysis Solutions

Study Results

No Results Posted as of Feb 15, 2013